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← ZELBORAF: unresectable metastatic Melanoma with BRAF V600E

NCT01682083 · STUDY IN CONTEXT

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

Draft scope assessment: unclear. Attached because the study's own record names BRAF. The study record does not state V600E, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.

Intent-to-Treat (ITT) Population

primary · POSTED

Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.

Intent-to-Treat (ITT) Population

secondary · POSTED

Censoring was performed using the date of last known contact for those who were alive at the time of analysis.

Intent-to-Treat (ITT) Population

secondary · POSTED

Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.

Intent-to-Treat (ITT) Population

secondary · POSTED

Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.

Intent-to-Treat (ITT) Population

secondary · POSTED

Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.

Intent-to-Treat (ITT) Population

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-melanoma-zelboraf-2db9cb76
nct id: NCT01682083
trial label: Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
applicability: unclear
applicability note: Attached because the study's own record names BRAF. The study record does not state V600E, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0000
source section id
NCT01682083-om-0000
source outcome index
0
endpoint
Percentage of Participants With Relapse-free Survival (RFS) Events
endpoint definition
Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
time origin
Approximately 4 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0001
source section id
NCT01682083-om-0001
source outcome index
1
endpoint
Relapse-free Survival (RFS)
endpoint definition
Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
time origin
Approximately 4 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0002
source section id
NCT01682083-om-0002
source outcome index
2
endpoint
Percentage of Participants With Overall Survival (OS) Events
endpoint definition
Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
time origin
Approximately 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0003
source section id
NCT01682083-om-0003
source outcome index
3
endpoint
Overall Survival (OS)
endpoint definition
Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
time origin
Approximately 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0004
source section id
NCT01682083-om-0004
source outcome index
4
endpoint
Percentage of Participants With Distant Metastasis-free Survival (DMFS) Events
endpoint definition
Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.
time origin
Approximately 4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0005
source section id
NCT01682083-om-0005
source outcome index
5
endpoint
Distant Metastasis-free Survival (DMFS)
endpoint definition
Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.
time origin
Approximately 4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0000
arm key
OG000
arm label
Dabrafenib and Trametinib Combination Therapy
regimen
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
analyzed count
438
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0000
arm key
OG001
arm label
Dabrafenib and Trametinib Placebos
regimen
Subjects received matching placebos orally for 12 months
analyzed count
432
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0001
arm key
OG000
arm label
Dabrafenib and Trametinib Combination Therapy
regimen
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
analyzed count
438
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0001
arm key
OG001
arm label
Dabrafenib and Trametinib Placebos
regimen
Subjects received matching placebos orally for 12 months
analyzed count
432
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0002
arm key
OG000
arm label
Dabrafenib and Trametinib Combination Therapy
regimen
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
analyzed count
438
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0002
arm key
OG001
arm label
Dabrafenib and Trametinib Placebos
regimen
Subjects received matching placebos orally for 12 months
analyzed count
432
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0003
arm key
OG000
arm label
Dabrafenib and Trametinib Combination Therapy
regimen
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
analyzed count
438
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0003
arm key
OG001
arm label
Dabrafenib and Trametinib Placebos
regimen
Subjects received matching placebos orally for 12 months
analyzed count
432
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0004
arm key
OG000
arm label
Dabrafenib and Trametinib Combination Therapy
regimen
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
analyzed count
438
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0004
arm key
OG001
arm label
Dabrafenib and Trametinib Placebos
regimen
Subjects received matching placebos orally for 12 months
analyzed count
432
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0005
arm key
OG000
arm label
Dabrafenib and Trametinib Combination Therapy
regimen
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
analyzed count
438
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
outcome key
om-0005
arm key
OG001
arm label
Dabrafenib and Trametinib Placebos
regimen
Subjects received matching placebos orally for 12 months
analyzed count
432
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01682083-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
harm key
EG000
source section id
NCT01682083-ae
event group key
EG000
event group label
Dabrafenib + Trametinib Combination Therapy
serious affected
155
serious at risk
435
other affected
414
other at risk
435
frequency threshold
5
collection period
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
event definition
Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
harm key
EG001
source section id
NCT01682083-ae
event group key
EG001
event group label
Dabrafenib and Trametinib Placebos
serious affected
44
serious at risk
432
other affected
343
other at risk
432
frequency threshold
5
collection period
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
event definition
Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
harm key
EG002
source section id
NCT01682083-ae
event group key
EG002
event group label
Dabrafenib + Trametinib Combination Therapy (Post-treatment)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
5
collection period
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
event definition
Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-zelboraf-2db9cb76
nct id
NCT01682083
harm key
EG003
source section id
NCT01682083-ae
event group key
EG003
event group label
Dabrafenib and Trametinib Placebos (Post-treatment)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
5
collection period
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
event definition
Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice